Inhaled Medication Delivery in Mechanically Ventilated Patients –

Saving money and Quality can co-existReturn to another time, Back to the Future,

or a work in Progress?

William R Howard MBA, RRT

Survey

• HME vs. active humidification circuit

• IBD by MDI

NCSRC 2012 Symposium

Consider: AARC promoted aerosol therapy concepts:1

• the right dose is technique and delivery system-dependent

• billions of dollars are spent on aerosol medications• you can have a profound impact to match medications

with delivery device to your patients

Ask yourself: in delivery of IBDs to MV patients:� the most cost-effective and� the most beneficial delivery method for your patient

1. Ari A, Hess D, Myers, Rau J. with a forward by Giordano S. A Guide to Aerosol Delivery Devices for Respiratory Therapists, 2nd Edition. 2009 American Association for Respiratory Care.

So – why am I here and what’s my story?

� Medical Director - 25 years ago challenge and expectation -

� Do not follow the standard of care – ESTABLISH it!

� Discuss 2 success stories – help pay back your symposium fee

• Hospital/department costs - daily demands to find savings

• Engage you as the instrument of change

The Objectives

• To identify realistic and significant savings in the administration of inhaled medications while increasing efficiency.

• To describe and demonstrate success changing from decades-old MDI to a cost-savings alternative.

• To identify barriers, partners, and change management strategy that will result in your having the same success.

Address one of the most common practices in the respiratory therapist’s profession:

� Inhaled bronchodilator administration in the MV patient

� Challenge the current “SOC” -• MDIs with or without spacers• Unit dosing

• Is SOC a contradiction in terms?

� Surveys: opinions from our peers at academic medical centers� Barriers/opposition/partners, the inertia/resistance, reluctance to change:

Physicians, nurses, RTs, and pharmacy � YOU can add benefit to your patient while saving $$� Implementation success story

What we will cover –

What we will not cover – the science (at least most of it)

Recommend reading -

1. Ari A, Areabi H, Fink J. Evaluation of aerosol generator devices at 3 locations in humidified and non-humidified circuits during adult mechanical ventilation. Respir Care 2010;55(7):837-844

2. Ari A, Atalay OT, Harwood R, Sheard MM, Aljamaa EA, Fink JB. Influence of nebulizer type, position, and bias flow on aerosol drug Respir Care 2010;55(7):845-851.

3. Duarte A. Inhaled bronchodilator administration during mechanical ventilation. Respir Care;2004 ;49 (6).4. Dolovich M. Changing delivery methods for obstructive lung diseases. Curr Opin Pulm Med 1997;3(3):177–189.5. Fink JB, Dhand R. Laboratory evaluation of metered-dose inhalers with models that simulate interaction with the

patient. Respir Care Clin North Am 2001;7(2):303–317.6. Fink JB, Dhand R, Grychowski J, Fahey PJ, Tobin MJ. Reconciling in-vitro and in-vivo measurements of aerosol

delivery from a metered-dose inhaler during mechanical ventilation, and defining efficiency enhancing factors. Am J Respir Crit Care Med 1999;159(1):63–68.

7. Everard ML, Devadason SG, Le Souef PN. In vitro assessment of drug delivery through an endotracheal tube using a dry powder inhaler delivery system. Thorax 1996;51(1):75–77.

8. Duarte AG, Dhand R, Reid R, Fink JB, Fahey PJ, Tobin MJ, Jenne JW. Serum albuterol levels after metered-dose inhaler administration to ventilated patients and healthy controls. Am J Respir Crit Care Med 1996;154(6 Pt 1):1658–1663.

9. Dhand R. Inhalation therapy with metered-dose inhalers and dry powder inhalers in mechanically ventilated patients. Respir Care 2005;50(10):1331–1344.

Why suggest change from MDIs – used for decades – to unit dose (UD) IBDs?

Is this crazy?

Or said another way: “why have we been using MDIs?”

Motivation began with completion of AARC Asthma educator certification course.

EDUCATION!

Why the focus is on MDI – and the ventilator circuit?

Consider:

� Drug deposition after actuation: variety of locations for deposits-� the actuator� the ventilator circuit� the endotracheal tube

� The amount of drug reaching the distal end of the ETT is available for deposition in the lung…but 1st…� a small proportion of this drug is exhaled and � a variable amount is systemically absorbed. � The remainder of the drug deposits in the lung (the lung

dose) - responsible for the pharmacologic effects� Patient response to inhaled drug directly related to amount

of deposition in the lower respiratory tract.

Our job is not done…

= Less drug available to reach target

Less and less drug

Why we are not done –

• Delivery device: less than adequate; so little of “nominal dose” is delivered.

• Variability – no consensus

Surveys:• Several national (informal peer surveys)

• US academic medical centers – during past 3 years• common theme re: delivery methods for inhaled bronchodilators...

1) MDI proponents: “We have a protocol that dictates the use of MDIs instead of SVNs in mechanically ventilated patients. An option for SVNs is not given in those patients.”

2) Unhappy “unit-dosers” who want the MDI option:

o “Has anyone been able to move away from unit dose to MDI?”

� Tufts, Southcoast and many others:

� MDIs – ICU and floors for 30 years - until very recently

There is no agreement on a single SOC

My response to each survey:

1. Why reluctance for unit dose (UD)?2. MDIs –

• Evidence of superiority? • HHN at least equivalent!

3. HFA propellants, less drug delivery than CFC4. Ventilator settings – adjust for breath hold prior; & DC after each Rx5. We switched to unit dose A&A and Combivent for all MV patients (2009)6. Practice fully endorsed by pulmonary group; we have not turned back.

7. Net savings ~ $100/patient (2009 $$). 8. Savings even more with UD budesonide substituted for MDI Fluticasone.

END OF EMAIL THREAD……………….

#1 reason for not switching over to unit dose? (e-mail/phone call follow-up)

The savings will not come out of “My budget”

……. My Department will have added costs and

it’ll affect My bottom line” - All reasonable but…

The silo mentality

The “Boston – attitude; cross-town rivalry” October 2010 from RT Director at a major Boston Teaching Hospital –

Speculation from ‘cynics” -

“Bill – I am curious as to how you can save $ using the

Aerogen. Aren’t you using this at $40 each?”

The # 2, 3, 4, etc. reasons for not switching over to unit dose – until now?

� ? denial that there is a more effective methodHow can I be wrong with my current method?

� ? Ego� Financial attractiveness not apparent

� “We’ve always used MDI”� Mis-perceptions, or reservation due to educational challenges?

The “Boston-attitude”

August 11, 2011 e-mail/follow-up phone call from RT Director at even BIGGER Boston Teaching Hospital -

• Aerogen neb is being considered as an alternative delivery system for “………..” but we never considered it for IBDs.”

• I am amazed that Tufts saved ~ $100.00/patient as an MDI replacement.

Consideration……………………..

August, 2011 e-mail from clinical manager at a Children's Hospital in Boston:

“We are looking for alternatives to deliver continuousalbuterol delivery”

“I was wondering if you could tell me a little about how you use the Aerogen device in this capacity.”

Slowly making headway………

Hartford Hospital Connecticut query –

February, 2012 e-mail from clinical manager:

“We spoke a few months back about your use of UD for IBD at Tufts.”

• “We are still looking to initiate the use of this nebulizer at our institution and I've been asked to give evidence of cost savings and its increase in efficacy of care to our VP of Patient Care Services.”

H.H. cost for Combivent: $196.00 each!

Slowly making headway………

Most recent – 3 hospital systemJanuary, 2012

On radar screen since 2010; never went forward.

Remained - “Interested”

Purchasing M.D.sRT

educator

Pharmacy

(new Exec. Dir)Infectious

disease

Financial

experts

Combivent @

$198.00 each -

2500 canisters

dispensed

annually

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From Background to “the Original Plan”: Convert MDI delivery IBD to UD aerosol administration with MV patients.

Initial plan (2009) was a discussion of:

potential alternatives to i-NO .

Bigger picture – convert decades old practice of MDI use to unit dosing……

The Original Plan: Convert MDI delivery of inhaled bronchodilators to unit dose aerosol administration.

The story that brought the opportunity into Tufts

• Initial target audience to address –

• Change 30 years of IBD MDIs to UD

1 person

Chairman of adult pulmonary division

Respiratory Care Medical Director

(immediate past President of

American Thoracic Society)

Began with description of vibrating mesh nebulizer:

Technology - deliver aerosolized medications approved for general purpose nebulizers - through mechanical ventilators.

Phase -1

Explained the barriers: Popular current generation ventilators – powering the neb?

“Available” nebulizers – separate gas source required

Akita II

E-Flow (PARI)

OmronHealthcare)

Aeroneb® Go and Solo

Features of the Vibrating Mesh technology

� No added flow or volume from neb

� No pressure/volume loss when adding UD

� No VAP protocol violation (circuit remains closed)

� Convenient for the staff; time saver over MDI

� For routine intermittent or continuous Rxs

� Numerous inhaled medications

� Remains with patient throughout hospital stay� Evidence - deposits up to 4 X more medication through an endotracheal tube (in

vitro) during mechanical ventilation than small volume nebulizers (SVNs).

� Remember the evidence: MDI and SVN = comparable delivery

2009 original Plan: Convert MDI delivery of inhaled bronchodilators to unit dose aerosol administration.

Unlike pre “current generation” ventilators:

• No flow to nebulize inhaled medications.

Prior to newer nebulizers:

• To nebulize inhaled meds with standard SVN

• Change mode AC/SIMV to PCV/Bi-Level• AC with SVN - higher airway pressure generation.

• PCV/Bi-Level protects against added VT/Pawp from SVN• Often – not always requires more sedation

• Risk of ventilator failure, (SVM) monitoring and alarm violation if flow too high1

The RIGHT FIT……..

1. Lichtenfels E, Boas G, Oberly D. EVALUATION OF THE WESTMED VIXONE NEBULIZER WITH THE MALLINCKRODT NELLCOR PURITAN BENNETT 840 VENTILATOR. AARC 2006 OF-01-001

Aerosol delivery(selling points to medical director)

� The evidence vs. the Perceptions - references

� 30+ years ago when MDIs introduced: MDI superior?

• MDI delivery comparable to SVNs – if ‘ideal’ techniques used

• …. but not necessarily superior to SVN

THE picture/ that spoke 1,000 words –

and sold my medical director –

Rx with Aerogen nebulizer during

bronchoscopy

Aerosol delivery

Target: IBD alternatives to MDIs –

� Unit dose (available in formulary – the low hanging fruit – the easy sell)

� Initially - short acting bronchodilators and anticholinergics

• Albuterol, Atrovent (Combivent)

� Secondary - Inhaled corticosteroids

• Pulmicort/Fluticasone (budesonide)

• Abs

� Continuous

� Bronchodilators

Goal : sell to the M.D. champion(s)

Comparison of MDI to unit dose

MDI:

Perceived benefits or advantages

• Convenient and less labor

• Delivery superior to liquid nebulized medication administration

• MDIs cost effective alternative to unit-dose solution.

MDI Disadvantages:

• More labor/TIME involved in delivery of treatment if performed correctly.• Needs “to be performed correctly” to be effective.

• Spacer, proper coordination, timing of each actuation, 60 second pause between actuations.

• Multiple ventilator circuit breeches with each treatment.• MDI removed from ventilator circuit and re-inserted for each subsequent treatment

• Requires breath hold especially with the new HFA propellant.• “Tailing off” – as MDI is depleted, dose declines; • When is MDI empty?

• H20 bath content determination useless with HFAs• Counters do not work with Mech. Vent circuit spacers.

• More priming needed – (wasted doses) with HFA MDI• HFA MDIs cost more than CFC MDIs or UD

• Wasteful if canister is not used completely. (Many of our ventilated patients use partial canisters)

• Bedside storage/security concerns• Can not/should not be returned to Pyxis – ID/contamination issues.

Goal : more points attempting to sell/influence M.D. champion(s)

Comparison of MDI to unit dose

Unit Dose Advantages

� Timing and coordination of actuation a non-issue.

� No lost therapist time/pausing of treatment delivery

� Each dose is the same; no “tailing off” with subsequent Rx.

� Evidence Aerogen nebulizer - drug delivery to the patient:

• min of 83% of aerosol in the perfect respirable range

• drug delivery 4 X more than MDI or SVN “equivalent” ordered dose.

� Unit dose; there is no unused medication – no waste!

� Single patient use - no security or ID factors

Unit Dose Disadvantages

PERCEPTIONS:

• “We’ve always used MDIs they must be better”

• “We have been there – we are going backwards by nebulizing”

Goal : sell to the M.D. champion(s)

Metered-dose to unit dose – dose equivalency

Short-acting ß2 agonist

� Albuterol 2.5 mg/2.5 ml

• (3 puff MDI equivalent) **

Anticholinergics

� Atrovent 0.5 mg/2.5 ml

• (3 puff MDI equivalent) **

** To deliver an equivalent 6-8 puff MDI dose, 2 ampoules of unit-dose will be required for each Rx

Goal : sell to the M.D. champion(s)

Initial concern – comparable dose deliveryIdentified historical average dose to be 6 -8 puffs/Rx (CFC)

Neb cup capacity – 6 mL

MDI : Single dose – dosage comparisons

Combivent :

• Albuterol 2.5 mg/2.5 ml

• (3-4 puff MDI equivalent) **

• Atrovent 0.5 mg/2.5 ml

• (3-4 puff MDI equivalent) **

To deliver an equivalent 6-8 puff MDI dose, 2 ampoules of UD = 6 mL.

1- ampule of Duoneb

Unit Dose - Gaining Acceptance

Phase 2 - ~ 2 years after initial ICU implementation:

� The target – M&S/non-ICU patient floors

� The mission – IBD MDI discontinuance

� The belief – no downside treating patients with IBD (and i-steroid) with unit dose rather than MDI.

� Line in the sand –

…… why should we pay for the most expensive delivery method (MDI) while in the hospital?

The “challenges” –

Unit Dose - Gaining Acceptance

Phase 2 - ~ 2 years later (cont’d)

� Challenge #1 – physician education

� Both unit dose (PRN) and MDI of same medication often ordered for same patients.

� M.D. #1 concern

• “I want to transition my patient to home with MDI”

Response:

� Most patients on Rx are not new starts

� Should not equate to MDI delivery for total hospital stay.

� No cost or effectiveness justification for MDI.

� Placebo teach pre-discharge

Unit Dose - Gaining Acceptance

Phase 2 - ~ 2 years later (cont’d)

Challenge #2 – nursing education

� Perception that most ‘scheduled’ Rxs would take more time

• Education: issues with MDI delivery discussed earlier

� Placebo MDI for 'new start' pre-DC education

� …… reminder that MOST patients going home with IBDs (COPD) already had MDI education; these are not new starts.

� Addressed ID and JCAHO issues with return of MDIs to Pyxis vs unit dose

Tufts Medical Center partners/opportunities:

Pharmacy – proposal and endorsement from P&T:

� MDIs when properly used are at least as effective as nebulized solutions.

� The economics have changed. New environmentally friendly’ MDIs significantly more expensive.

� In the past 6 months we have spent more on respiratory medications than on antibiotics or chemotherapy!

� Proposed policy: automatic substitution of MDIs to unit dose - albuterol, Atrovent, Combivent, and Fluticasone.” (APPROVED)

• Approached initially - 2010 – $$ identified

• Acknowledged benefits for the patient

• No forward progress - until Jan-2012

� The same target: MV patients

� The practice:

� MV patients - MDI - Combivent

� Cost (identified Opportunity-1)

� Dosing efficiency (Opportunity-2)

� Barriers – HME circuits = (Opportunity – 3)

� - not considered by in-house ‘sponsor’ as a barrier

� “we’ve always done it this way” (HME circuit)

� - absence of HME practice monitoring: patient assessments

� Actual vs. perceived HME cost

New opportunity - Southcoast Hospitals Group

The next chapter:

� Barriers – HME circuit - not considered a barrier

� “we’ve always done it this way”

� - absence of HME practice monitoring:

� Patient assessments

� Every exclusion criteria routinely met

� 2 acute airway obstructions with HMEs

� HME with optional flow path

� Is it possible HME directed flow path will not be reset or re-adjusted after Rx?

� If it can happen it will (not)

The next chapter:New opportunity - 3 Hospital Group

Project – change from passive to active humidification

Humidification of artificial airways

Passive or active?

Project – change from passive to active humidification

Debate - read the science -

Drug delivery from the vibrating mesh nebulizer was 2–4-fold greater than that from the jet nebulizer under all test conditions

1. Ari A, Areabi H, Fink J. Evaluation of aerosol generator devices at 3 locations in humidified and non-humidified circuits during adult mechanical ventilation. RespirCare 2010;55(7):837-844

2. Ari A, Atalay OT, Harwood R, Sheard MM, Aljamaa EA, Fink JB. Influence of nebulizer type, position, and bias flow on aerosol drug Respir Care 2010;55(7):845-851.

3. DiBlasi R.Clearing the mist from our eyes: bronchodilators, mechanical ventilation, new devices, locations, and what you should know about bias flow. Respiratory Care. • July 2010;55(7).

4. Ari A, Hess D, Myers, Rau J. with a forward by Giordano S. A Guide to Aerosol Delivery Devices for Respiratory Therapists, 2nd Edition. 2009 American Association for Respiratory Care.

The Plan:

Replaced HME circuit with active humidification in conjunction to Aerogenimplementation

� Selling points to leadership:

� Investment in active humidification

� Overall savings with improvements in clinical practice

� Barriers – selling to admin.

� Pushback from MDs who prefer MDIs

� 1st round – group meeting with Pulmonologists

� 2nd round – staff acceptance

� 3rd round – P&T Committee

New target – 3 hospital group

The next chapter:

• Defiant M.D - pulmonologist

• Wanted comparison of MDI to VM delivery/efficiency

• Not buying ATS President story

• Suggested - paid by Aerogen

• The gauntlet thrown- $100.00 wager

• …my last slide – (coming soon) $$ saved

(Opportunity – 4): sell to M.D.s (Pulmonologists) at their quarterly meeting (4 attendees)

New organization – non-academic medical center but……….

The next chapter:

• To all pulmonary M.D.s across the 3-hospital system

• EDUCATE –

• Letter

• Slide set

• Evidence; References

• Target: Same as at Tufts

• MDIs – UD alternatives

Goal #2: all Pulmonologists

New organization – non-academic medical center but……….

The next chapter:

Letter(s) and meetings :

• Team Leaders and staff

• Educator

• Purchasing

• Divisional VP - Finance

• Pharmacy

• Pharmacy Finance Manager

• Expense and savings details

• Aerogen consumables

• Ventilator circuit

• Medication SAVINGS

Goal: convert all 3 hospital sites

The next chapter:

THE UNIVERSAL MESSAGE – MY MESSAGE - STATED AT EACH MEETING TO ALL AUDIENCES:

“There is absolutely no logical or scientific reason that we should be administering IBD medications using the most expensive method that we have – MDI where there is a UD alternative!”

Goal : influence all stakeholders

Anticipated net savings to -

• $198.00/canister (equivalent to 5 days of Q4H or 25 treatments)

• Compare: UD equiv: $7.25 plus $40.00 neb cup = $47.25

• SAVINGS: $198.00 – 47.25 + 7.00 Incr cir cost ~=$143.00/patient or ~ $190,000 annually……

Savings will be significantly more - many MV patients receive > 1 MDI canister (average = 1.5/patient)

Additional savings - unit dose budesonide vs. MDI Fluticasone.

“Why single dose - why now?”

UNIT/ DEVICE COST

UNITS/ DEVICES

DISPENSED FY2011**

ANNUAL Patient

VOLUME

ANNUAL SPEND

SUBSTITUTION (THERAPEUTIC INTERCHANGE- AEROGEN nebulizer)

UNIT COST

PROJ ANNUAL VOLUME

PROJ ANNUAL

COST

IncrmtalCost incr

POTENTIAL ANNUAL SAVINGS

MDI BRONCHODILATORS

COMBIVENT (200) 198.00 1,800 1,200 356,400 DuoNeb 0.29 23,040 6,682 $349,718

Aerogen Neb 40.00 1,200 48,000 48,000

SUB-TOTAL 356,400

PROJECT: HME vs Active Humid POTENTIAL COST SAVINGS 3/1/12 SHG

UNIT/ DEVICE COST

ANNUAL Patient

VOLUME

(Active humidification circuit)

F&P Dual Heated Wire circuit w/chamberHME circuit 13.50 1,200 16,200 27.00 1,200 32,400 16,200

TOTAL SPEND 372,600 84,682 64,200 285,518

Annual Net SAVINGS $285,518

What if………………….

100,000 MV patients hospitalized/year

What if...

50% receive IBDs by MDI

X $240** savings ea

= 50K x $240 or

$12,000,000

**Assumes average of 2 MDI canisters/ patient on MV

Who made the conversion work?

My staff were the pleasant surprise� Very accommodating of another change� Unsolicited compliments

� The system easy to use � Less time/labor� Very pleased with the switch from MDIs

• The staff made the switch from decades old MDI method of delivery painless.

Unit Dose - Gaining Acceptance

So is the message being heard?

So is the message being heard?

Inhaled Bronchodilators…. Old Habits die hard

� MDI practice – MV - is now ~ 30 years old

� The science is solid

� Barriers are real – change is difficult

� Initial sticker shock - mis-perceptions

� Financial opportunities –

� YOU are the CHAMPION of CHANGE!

…follow the money and provide a better Rx @ the same time

Good luck--

Follow-up questions and communication:

BillHoward@CuffSentry.com

My time is done - thank you for yours……….

1. Hess D. Aerosol delivery devices in the treatment of asthma. Respir Care 2008;53(6):699 –723.

2. Dhand R. The role of aerosolized antimicrobials in the treatment of ventilator-associated pneumonia. Respir Care 2007;52(7):866–884.

3. Dolovich M, Ahrens R, Hess D, Dhand R, Rau, J. Device Selection and Outcomes of Aerosol Therapy. CHEST 2005; ;127(1):335-371

4. Duarte A. Inhaled bronchodilator administration during mechanical ventilation. Respir Care 2004;49(6):623–634.

5. Dhand R. New frontiers in aerosol delivery during mechanical ventilation. Respir Care 2004;49(6):666 – 677.

6. Fink JB, Tobin MJ, Dhand R. Bronchodilator therapy in mechanically ventilated patients. RespirCare 1999;44(1):53-69.

7. O'Riordan TG, Palmer LB, Smaldone GC. Aerosol deposition in mechanically ventilated patients: optimizing nebulizer delivery. Am J Respir Crit Care Med 1994;149(1):214-219.

8. Crogan SJ, Bishop MJ. Delivery efficiency of metered dose aerosols given via endotrachealtubes. Anesthesiology 1989;70(6):1008-1010.

9. Bishop MJ, Larson RP, Buschman DL. Metered dose inhaler aerosol characteristics are affected by the endotracheal tube actuator/adapter used. Anesthesiology 1990;73(6):1263-1265.

Additional References: